Device product

UMBILICAL VESSEL CATHETER KIT CUSTOMED 8/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

Z-2583-2015

July 10, 2015

Class II

Product summary

Firm: Customed, Inc
Event: Event 71721
Status: Terminated
Classification: Class II
Quantity: 48 kits
Official record key: device-enforcement:Z-2583-2015

Official wording

Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.

Code information: Code:9001408 Lots: 141015796 exp. 4/30/15 140814647 exp. 6/30/16

Distribution pattern: Distributed Only in Puerto Rico.

Derived failure modes

Manufacturing or process control
reason.manufacturing_process_control · v1.0.0

inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0

inadequate validation/qualification of sterilization